ICSSES: Impact of Cataract Surgery to Socioeconomic Status in Rural Area

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT03020056
Collaborator
(none)
292
1
2
17.4
16.8

Study Details

Study Description

Brief Summary

This is a randomized controlled trial to investigate the effect of cataract surgery on the socioeconomic status of cataract patients in rural area of Southern China.

Condition or Disease Intervention/Treatment Phase
  • Drug: Phacolin eye drops
  • Procedure: cataract surgery
N/A

Detailed Description

Cataract is the leading cause of visual impairment worldwide and surgery is the only effective treatment. Previous studies show that visual impairment impacts the patient's socioeconomic status(SES). However, how cataract surgery affects the SES of cataract patients in rural area of China has not been determined before.

In the investigators study, cataract patients in rural area of Southern China will be enrolled and randomly divided into two groups. Cataract surgery will be performed in 4 weeks in intervention group, while performed at 1 year later in control group. The annual personal income by work, annual household income, hours in paid and unpaid work in the previous month, real estate ownership, household expenditures and quality of life will be investigated before and 1 year after surgery. Then, the difference in SES and quality of life change between two groups at 1 year later will be assessed.

Study Design

Study Type:
Interventional
Actual Enrollment :
292 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Impact of Cataract Surgery to Socioeconomic Status in Rural Area of Southern China: A Randomised Controlled Trial
Actual Study Start Date :
Jan 16, 2017
Actual Primary Completion Date :
Jun 29, 2018
Actual Study Completion Date :
Jun 29, 2018

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: waiting surgery

Cataract surgery will be performed at 1 year after enrollment.These participants will be provided with Phacolin eye drops(Zhongshan ophthalmic center, China).

Drug: Phacolin eye drops
After enrollment, the participants will be provided antioxidant eye drops, Phacolin (Zhongshan ophthalmic center, China) for free.The eye drops will be administered 4 times per day for 1 year.Then either phacoemulsification or manual small incision cataract surgery will be performed.
Other Names:
  • antioxidant eye drops
  • Experimental: expedited surgery

    Cataract surgery will be performed within 4 weeks.

    Procedure: cataract surgery
    After enrollment,either phacoemulsification or manual small incision cataract surgery will be performed within 4 weeks.
    Other Names:
  • phacoemulsification or MSICS
  • Outcome Measures

    Primary Outcome Measures

    1. annual personal income by work in Chinese Yuan [1 year]

      The annual personal income comprises of the direct and the indirect income by work. The indirect income is derived from unpaid work and calculated as follows: unpaid work time × local income per hour.

    Secondary Outcome Measures

    1. Health-related quality of life score [1 year]

      Health-related QoL score will be measured by EuroQol 5 dimensions with 5 levels (EQ-5D-5L) and self-rated health (SRH). For each dimension, participants are asked to mark between 1: "no problems" to 5: "unable to/extreme problems". Self-rated health using a vertical Visual Analogue Scale (VAS), with scores ranging from 0 (representing worst imaginable health state) to 100 (best imaginable health state). mobility self-care usual activities pain/discomfort anxiety/depression f: self-rated health

    2. Vision related quality of life score [1 year]

      Vision related QoL score will be measured by Catquest-9S, which is a short form of Catquest questionnaire. The Catquest-9SF questionnaire comprises 7 questions for performing daily-life activities and 2 global questions about difficulties in general and satisfaction with vision (1= very great difficulty; 2= great difficulty; 3= some difficulty; 4= no difficulty). reading text in the newspaper recognizing faces of people you meet seeing prices of goods when shopping seeing to walk on uneven ground seeing to do needlework and handicraft reading text on television seeing to carry out a preferred hobby difficulty in daily life satisfaction on present vision

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age-related cataract patients aged over 50 with best corrected visual acuity (BCVA) less than 0.3 in the better eye.
    Exclusion Criteria:
    • History of other eye disease that contributes to visual impairment, including keratopathy, uveitis, glaucoma, retinopathy, ocular trauma, or intraocular surgery.

    • Cases in need of expedited surgery, including shallow anterior chamber (central anterior chamber depth less than 2 mm and/or peripheral anterior chamber depth less than 1/4 corneal thickness), blindness of grade IV and V (BCVA less than 0.02 in the better eye), and intumescent or hypermature stage of cortical cataract.

    • Systemic disease dampening activity, including cardiovascular and cerebrovascular diseases, hemiplegia, neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease.

    • Patients not willing to participate in the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Huidong people's hospital Huidong Guangdong China 516300

    Sponsors and Collaborators

    • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Investigators

    • Principal Investigator: Yizhi Liu, Doctor, Zhongshan Ophthalmic Center, Sun Yat-sen University
    • Study Director: Yingfeng Zheng, Doctor, Zhongshan Ophthalmic Center, Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yizhi Liu, Clinical Professor,director of Zhongshan Ophthalmic Center, Zhongshan Ophthalmic Center, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT03020056
    Other Study ID Numbers:
    • 2016KYYJ007
    First Posted:
    Jan 13, 2017
    Last Update Posted:
    Mar 30, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Yizhi Liu, Clinical Professor,director of Zhongshan Ophthalmic Center, Zhongshan Ophthalmic Center, Sun Yat-sen University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 30, 2021